Real-world Study to Assess Adherence to IOP Lowering Therapy in Glaucoma Patients Using CONNECTDROP®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adherence to Glaucoma Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Study to Assess Adherence to IOP Lowering Therapy in Glaucoma Patients Using CONNECTDROP®: the GRANITE Study (Glaucoma tReatment AdhereNce wIth connecTed dEvice in Italy)
Overview
The goal of this real-life, national, multicentre, prospective clinical investigation is to describe the adherence rate over time in patients with glaucoma already treated with IOP-lowering eye drops using connected device CONNECTDROP® The main questions it aims to answer are: * The mean annual adherence rate, defined as the percentage of the prescribed doses taken by the patient * The adherence profile of each patient * The association between the adherence profile, the objective adherence data and the clinical data. Participants will use the connected device CONNECTDROP® associated with the smartphone application on a daily basis.
Primary outcome measures
- Adherence rate over time in patients with glaucoma already treated with IOP-lowering eye drops in EASYGRIP® bottle clipped with CONNECTDROP® [Time frame: From enrollment to the end of the study at 12 months]
Eligibility criteria
Inclusion criteria
- Adult patient (≥ 18 years old), man or woman
- Patient with a diagnosis of bilateral open angle glaucoma
- Patients being prescribed with glaucoma eye drops in EASYGRIP® bottle for at least 6 weeks in monotherapy.
- Patient willing to participate in the study
- Patient who consents for data collection in the frame of the study
Exclusion criteria
- Pregnant and/or lactating woman
- Patient receiving another ocular treatment for a chronic condition (i.e. regular instillations for several months)
- Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 17 centers
- Besomed SRLS — Bari
- Studio Oculistico D'Azeglio — Bologna
- Centro Medico Polispecialistico Di Maita — Catania
- Studio Medico Oculistico Dr.ssa Rosa SCHIAVELLI s.r.l. — Corigliano
- Ospedale Policlinico S. Martino-IRCCS Clinica Oculistica Università di Genova — Genova
- Poliambulatorio Chirurgico Modenese Eyecare Clinic — Modena
- Centro Oculistico Ramovecchi S.r.l. — Morrovalle
- AOU Federico II di Napoli Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontosto — Naples
- … and 9 more centers
Identifiers
NCT: NCT07206628 · LT9060-002